Senior Quality Assurance Manager
Tranquil Clinical and Research Consulting Services LLC•Webster, TX
•$95,000 - $115,000
About The Position
We are seeking an experienced and motivated Senior Quality Assurance (QA) Manager – Clinical Trials to further develop our QA function within the clinical research environment. This role combines hands-on quality expertise with close collaboration with cross-functional and international stakeholders.
Requirements
- University degree in Life Sciences, Pharmacy, Medicine, or a related field
- Several years of professional experience in Quality Assurance within clinical trials
- Senior QA professional
- Strong knowledge of GCP, ICH and international regulatory requirements (e.g. FDA regulations)
- Demonstrated experience in: Audit planning, performance, and reporting; Deviation and CAPA management; Risk management; Change management; SOP and training management
- Willingness to travel nationally and internationally, particularly within/to Germany, within Europe and the USA
- Strong organizational, analytical, and problem-solving skills
- Confident communication style and ability to work with stakeholders at all levels
Nice To Haves
- development into a team lead function
Responsibilities
- Plan, conduct, report and track internal and external audits (e.g. process audits, vendor qualification audits, system and study specific audits and inspections)
- Ensure compliance with GCP, ICH guidelines, FDA regulations, applicable regulatory requirements, and company standards
- Own and manage Deviation and CAPA processes, including root cause analysis, tracking, and effectiveness checks
- Drive risk management activities, including risk assessments and mitigation strategies
- Lead and support change management processes related to quality systems and clinical operations
- Responsible for the creation, review, approval, and lifecycle management of QA SOPs
- Preparation of role-based training materials and conduct of training courses in the GCP/FDA regulated setting
- Prepare quality metrics, management reports, and audit summaries for upper management
- Act as a key QA contact for regulatory inspections and sponsor audits
- Collaborate closely with Clinical Operations, Project Management, Regulatory Affairs, Data Management, Medical Writing and external partners
- Support continuous improvement initiatives within the Quality Management System (QMS)
- Review and approve validation documentation (e.g. validation plans, risk assessments, test scripts, validation reports) for computerized systems, including eQMS and other GxP-relevant systems
Benefits
- Performance-based compensation
- flexible working hours
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What This Job Offers
Job Type
Full-time
Career Level
Senior
